Multi-target bone rehabilitation physical therapy patch based on yin-yang balance compatibility and magnetoelectric infiltration promotion and preparation method of multi-target bone rehabilitation physical therapy patch
By combining Yin and Yang in a balanced formula with magnetic and electrical penetration-enhancing multi-target bone rehabilitation therapy patches, this product addresses the issues of insufficient transdermal depth, limited efficacy, and safety concerns associated with existing external bone disease patches. It achieves multi-target synergistic treatment and safe and highly effective bone rehabilitation, making it suitable for the prevention and rehabilitation of various bone diseases.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-31
- Publication Date
- 2026-03-31
AI Technical Summary
Existing topical patches for bone diseases suffer from problems such as insufficient transdermal depth, single efficacy, unclear bone penetration mechanism, and safety concerns. They are difficult to effectively penetrate to bone and joint lesions, cannot achieve multi-target synergistic treatment, and have the risk of drug toxicity and incompatibility.
This multi-target bone rehabilitation therapy patch, based on the principles of Yin-Yang balance and magnetoelectric permeation, uses a scientifically categorized and proportioned combination of traditional Chinese medicines for four main functions: promoting blood circulation and removing blood stasis, healing tendons and bones, relaxing muscles and tendons, replenishing Qi and blood, and dispelling wind and dampness. It also incorporates ferric oxide@gold nanorod composite particles and utilizes magnetoelectric permeation technology to enhance transdermal penetration efficiency. The patch is designed with a multi-target drug action matrix targeting bone diseases, combining traditional Chinese medicine theory with modern technology to ensure safety and effectiveness.
It achieves drug penetration depth ≥6cm, rapid onset of action (≤15min), sustained effect ≥72h, multi-target synergistic treatment of bone diseases, high safety, applicable to the prevention and rehabilitation of various bone diseases, reduces production costs, and is suitable for large-scale production.
Abstract
Description
Technical Field
[0001] This invention relates to the field of external preparations of traditional Chinese medicine, specifically to a multi-target bone rehabilitation physiotherapy patch based on yin-yang balance and magnetic-electric permeation, and its preparation method. Background Technology
[0002] Patches are widely used in daily life as commonly used, portable, and convenient medications; however, existing topical patches for bone diseases face three major bottlenecks, as follows: First, the transdermal depth is insufficient: traditional plasters only reach 2mm under the skin, making it difficult to penetrate to bone and joint lesions and thus unable to effectively act on deep lesion sites. Secondly, the efficacy is singular and limited: most patches only target a single pathological link such as pain relief or blood circulation promotion, lacking a multi-target synergistic consideration of treating both the root cause and the symptoms (the root cause is insufficient liver and kidney, deficiency of qi and blood; the symptoms are qi stagnation and blood stasis, cold and dampness obstructing the collaterals, and malnutrition of tendons and bones), making it difficult to fundamentally improve the condition. Third, there are unclear mechanisms of action and potential safety risks: the drug's action pathway mainly relies on passive diffusion, which cannot accurately activate the body's own endogenous repair mechanisms; at the same time, some products may have problems with improper control of the toxicity of medicinal materials (such as containing highly toxic medicinal materials such as Aconitum carmichaelii and Aconitum kusnezoffii) or the irritating components (such as frankincense and myrrh raw products) have not been properly processed, which can easily cause safety risks such as skin allergies. In addition, some products have unbalanced formulations, either being too warm and dry and damaging Yin, or too nourishing and greasy and hindering Yang, which further affects the therapeutic effect and safety.
[0003] It is evident that providing a physiotherapy patch with excellent effects due to the synergistic effect of raw materials is of great significance. Summary of the Invention
[0004] In view of this, the present invention provides a multi-target bone rehabilitation therapy patch based on Yin-Yang balance and magnetoelectric permeation enhancement, and its preparation method. This bone rehabilitation therapy patch optimizes efficacy through Yin-Yang balance, enhances penetration through magnetoelectric permeation enhancement, and achieves precise synergistic effects through a multi-target matrix, effectively overcoming the technical bottlenecks of traditional bone rehabilitation patches. It retains the safety of traditional Chinese medicine external preparations while incorporating the precision of modern technology, providing a completely new solution for the treatment of bone diseases. The bone rehabilitation therapy patch provided by this invention integrates the traditional Chinese medicine theory of Yin-Yang balance with modern magnetoelectric permeation enhancement technology. The resulting rehabilitation therapy patch is suitable for the prevention, control, and rehabilitation treatment of bone diseases and related chronic conditions such as neck, shoulder, and lumbar pain, arthritis, osteonecrosis, and post-fracture rehabilitation.
[0005] The technical solution of the present invention is as follows: A multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation, each patch contains 19g of traditional Chinese medicine composition, which includes the following components by weight: The composition includes 5.2g of blood-activating and stasis-removing composition, 4.5g of tendon-repairing and bone-setting composition, 3.6g of muscle-relaxing and collateral-activating composition, 3.1g of qi- and blood-tonifying composition, and 2.6g of wind-dispelling and dampness-removing composition.
[0006] Preferably, the blood-activating and stasis-removing composition comprises the following raw materials by weight: Angelica sinensis 0.53-0.56g, Ligusticum chuanxiong 0.40-0.43g, Carthamus tinctorius 0.27-0.29g, Prunus persica 0.27-0.30g, Salvia miltiorrhiza 0.40-0.43g, Paeonia lactiflora 0.27-0.31g, Panax notoginseng 0.12-0.17g, Boswellia carterii (processed) 0.27-0.29g, Commiphora myrrha (processed) 0.28-0.32g, Corydalis yanhusuo 0.41-0.44g, Sappanwood 0.25-0.28g, Lycopus lucidus 0.27-0.30g, Artemisia capillaris 0.27-0.29g, Daemonorops draco 0.12-0.15g, Curcuma longa 0.25-0.30g, Curcuma aromatica 0.27-0.30g, Trogopterus xanthipes (vinegar-processed) 0.26-0.33g.
[0007] Preferably, the tendon-healing and bone-setting composition comprises the following raw materials by weight: Drynaria fortunei 0.53-0.55g, Dipsacus asper 0.39-0.42g, Calcined natural copper 0.40-0.43g, Fried ground beetle 0.25-0.30g, Eucommia ulmoides 0.39-0.42g, Cibotium barometz 0.25-0.28g, Epimedium 0.26-0.29g, Morinda officinalis 0.26-0.29g, Cuscuta chinensis (salt-processed) 0.25-0.30g, Taxillus chinensis 0.39-0.41g, Achyranthes bidentata 0.40-0.42g, Tortoise shell (vinegar-processed) 0.25-0.28g, Oyster shell (calcined) 0.25-0.31g.
[0008] Preferably, the muscle-relaxing and blood-activating composition comprises the following raw materials by weight: 0.45-0.49g of *Shenjincao*, 0.45-0.50g of *Tougucao*, 0.30-0.33g of *Weilingxian*, 0.45-0.49g of *Jixueteng*, 0.30-0.35g of *Luoshiteng*, 0.31-0.35g of *Haifengteng*, 0.30-0.33g of *Qingfengteng*, 0.30-0.33g of *Rindongteng*, 0.29-0.35g of *Sangzhi*, and 0.30-0.34g of *Sigualu*.
[0009] Preferably, the qi-tonifying and blood-nourishing composition comprises the following raw materials by weight: Astragalus membranaceus 0.60-0.65g, Codonopsis pilosula 0.43-0.47g, Rehmannia glutinosa 0.45-0.48g, Paeonia lactiflora 0.30-0.34g, Colla corii asini (melted) 0.30-0.33g, Ziziphus jujuba 0.30-0.32g, Glycyrrhiza uralensis (processed) 0.30-0.33g, Longan aril 0.30-0.34g.
[0010] Preferably, the wind-dispelling and dampness-removing composition comprises the following raw materials by weight: Angelica pubescens 0.28-0.31g, Notopterygium incisum 0.27-0.30g, Saposhnikovia divaricata 0.28-0.31g, Gentiana macrophylla 0.27-0.30g, Chaenomeles speciosa 0.29-0.33g, Siegesbeckia orientalis 0.27-0.30g, Geranium wilfordii 0.27-0.30g, Cinnamomum cassia twig 0.28-0.35g, Artemisia argyi (vinegar-processed) 0.27-0.29g.
[0011] In this invention, the ingredients are scientifically classified and proportioned according to five major functional categories: promoting blood circulation and removing blood stasis, promoting tendon and bone healing, relaxing muscles and tendons, replenishing qi and blood, and dispelling wind and dampness. The proportions of the five categories of ingredients are different. Among them, the category of promoting blood circulation and removing blood stasis and dispelling wind and dampness focuses on unblocking and eliminating, while the category of promoting tendon and bone healing and replenishing qi and blood focuses on tonifying and warming. This allows the patch to take into account four therapeutic effects: unblocking, tonifying, warming, and eliminating. It accurately balances the pathogenesis of bone diseases, which is characterized by deficiency of the root cause (i.e., insufficient qi and blood of the liver and kidneys) and excess of the symptoms (i.e., qi stagnation and blood stasis, cold and dampness obstructing the meridians). This avoids the problem of incomplete treatment caused by neglecting a single function, and at the same time solves the defects of unbalanced formulation in traditional patches.
[0012] The traditional Chinese medicine raw materials of this invention, in the blood-activating and stasis-removing composition, include: Angelica sinensis from Minxian County, Gansu Province; Ligusticum chuanxiong from Dujiangyan, Sichuan Province; Carthamus tinctorius from Ruoqiang, Xinjiang Province; Prunus persica from Xiuyan, Liaoning Province; Salvia miltiorrhiza from Juxian County, Shandong Province; Paeonia lactiflora from Duolun, Inner Mongolia Province; Panax notoginseng from Wenshan, Yunnan Province; Boswellia carterii from Luliang, Yunnan Province; Commiphora myrrha from Tunchang, Hainan Province; Corydalis yanhusuo from Dongyang, Zhejiang Province; Caesalpinia sappan from Baise, Guangxi Province; Lycopus lucidus from Yancheng, Jiangsu Province; Artemisia capillaris from Jurong, Jiangsu Province; Daemonorops draco from Danzhou, Hainan Province; Curcuma longa from Zhangzhou, Fujian Province; Curcuma aromatica from Shuangliu, Sichuan Province; and Trogopterus xanthipes from Yushe, Shanxi Province. This treatment utilizes 17 medicinal herbs to open local microcirculation channels, reduce inflammatory factor levels, and relieve swelling and pain caused by blood stasis. Among them, Angelica sinensis can open TRPV1 channels, promote local microcirculation, and reduce levels of inflammatory factors such as IL6 and TNFα; Ligusticum chuanxiong contains ligustrazine, which can promote local blood circulation; Carthamus tinctorius has high safety for external use and can help improve blood stasis; Prunus persica, after being stir-fried, can synergistically enhance the blood-activating effect without any safety risks; Salvia miltiorrhiza contains tanshinone components, which also have anti-inflammatory effects and cause no significant skin irritation when applied externally; Paeonia lactiflora contains paeoniflorin, which can exert anti-inflammatory and analgesic effects; Panax notoginseng contains notoginsenoside Rg1, which can promote tissue repair and causes no skin irritation when applied externally as a micro-powder; and Boswellia carterii (processed), after being processed to remove oil, is also included. The following ingredients have reduced irritation and contain boswellic acid, which can reduce inflammation and swelling: Myrrh (processed), also processed to remove oil, contains bisabolol, and has a significant analgesic effect; Corydalis, containing corydaline, has high bioavailability for external use and can effectively relieve pain; Sappanwood, containing brassicatinol, can assist in anti-inflammation; Lycopus lucidus, containing lycopodium clavatum, can improve local blood circulation; Artemisia capillaris, containing artemisia flavonoids, traditionally used externally to enhance blood circulation and anti-inflammatory effects; Dragon's blood, containing daemonone, has both anti-inflammatory and tissue-regenerating effects; Turmeric, containing curcumin, has a clear anti-inflammatory effect and high bioavailability for external use; Curcuma longa, containing curcuminoids, has no risk of hepatotoxicity for external use and can assist in blood circulation; Trogopterus xanthipes (vinegar-processed), after vinegar processing, has a reduced fishy smell and contains trogopterus xanthipes, which can promote local circulation. In the bone-setting and tendon-repairing composition, *Drynaria fortunei* is produced in Jiande, Zhejiang; *Dipsacus asper* in Leshan, Sichuan; *Natural copper* in Xinhuang, Hunan; *Eupolyphaga sinensis* in Xuzhou, Jiangsu; *Eucommia ulmoides* in Zunyi, Guizhou; *Cibotium barometz* in Wuyishan, Fujian; *Epimedium brevicornu* in Longnan, Gansu; *Morinda officinalis* in Deqing, Guangdong; *Cuscuta chinensis* in Anguo, Hebei; *Taxillus chinensis* in Nanning, Guangxi; *Achyranthes bidentata* in Wuzhi, Henan; *Tortoise shell* in Huzhou, Zhejiang; and oyster shell in Zhanjiang, Guangdong. Using 13 kinds of medicinal materials to promote the proliferation of osteoblasts, accelerate the formation of callus and the reconstruction of trabecular bone, and enhance the toughness of bones, achieving the effects of reconnecting tendons and bones and strengthening muscles and bones; among them, Drynaria rhizome can increase the expression level of BMP7 to promote the proliferation of osteoblasts, and at the same time increase the secretion of VEGF to assist in the reconstruction of trabecular bone; Dipsacus root contains asperosaponin VI and can promote the formation of callus; Pyritum (calcined), after calcination, divalent iron is more easily absorbed and can accelerate bone healing; Eupolyphaga seu Steleophaga (fried), after frying, the fishy smell is reduced, contains eupolyphagin I, and can promote tissue repair; Eucommia ulmoides contains eucommia gum and can promote the synthesis of collagen and enhance the toughness of bones; Cibotium barometz (parched) has no skin irritation after removing the villi by parching, contains filixic acid, and can promote local circulation to assist bone repair; Epimedium brevicornum contains icariin and has the effect of promoting osteogenesis; Morinda officinalis contains morinda officinalis polysaccharide, can enhance the immune function and provide support for bone repair; Cuscuta chinensis (salted), after salting, guides the drug to act on the lower jiao, contains cuscuta glycoside, and can assist in anti-inflammation to reduce the interference of bone injury inflammation; Taxillus chinensis contains taxilluside and can promote cartilage repair; Achyranthes bidentata contains achyranthes saponin, can promote local circulation and transport nutrients to bones; Testudinis carapax (vinegar processed), after vinegar processing to remove calcium and phosphorus, contains tortoise glue and can promote tissue repair; Concha ostreae (calcined), after calcination, contains calcium carbonate, can supplement bone minerals and assist in strengthening bones; In the composition for relaxing muscles and activating collaterals, Lycopodium clavatum is produced in Pan'an, Zhejiang; Speranskia tuberculata is produced in Haicheng, Liaoning; Clematis chinensis is produced in Xiangyang, Hubei; Millettia reticulata is produced in Nanning, Guangxi; Trachelospermum jasminoides is produced in Suzhou, Jiangsu; Piper kadsura is produced in Putian, Fujian; Sinomenium acutum is produced in Jinzhai, Anhui; Lonicera japonica is produced in Fengqiu, Henan; Ramulus mori is produced in Suzhou, Jiangsu; Luffa cylindrica is produced in Cixi, Zhejiang; Using 10 kinds of medicinal materials to inhibit synovial inflammation, loosen tissue adhesions, and improve joint mobility, achieving the effects of relaxing muscles and activating collaterals and dredging joints; among them, Lycopodium clavatum can inhibit the NFκB signaling pathway, reduce synovial inflammation, and effectively improve joint mobility; Speranskia tuberculata contains tuberculin, has a clear anti-inflammatory effect and strong external penetration ability, and can penetrate deep into the joint area; Clematis chinensis contains clematis saponin, can loosen tissue adhesions and relieve joint stiffness; Millettia reticulata contains millettia glycoside, can promote local circulation and provide nutrients for joints; Trachelospermum jasminoides contains tracheloside, has an anti-inflammatory effect and no skin irritation when used externally; Piper kadsura contains kadsurin and can exert an analgesic effect to relieve joint pain; Sinomenium acutum contains sinomenine, has a significant anti-inflammatory effect, and the dosage needs to be controlled to ensure safety; Lonicera japonica contains chlorogenic acid, can assist in anti-inflammation and has no contraindications when used externally; Ramulus mori contains ramulus mori polysaccharide, can promote local circulation and relieve blood stasis around joints; Luffa cylindrica contains luffa saponin, can loosen tissue adhesions and improve joint movement flexibility; In the composition for tonifying qi and blood, Astragalus membranaceus is produced in Longxi, Gansu; Codonopsis pilosula is produced in潞党, Shanxi; Rehmannia glutinosa (prepared) is produced in Wuzhi, Henan; Paeonia lactiflora is produced in Dongyang, Zhejiang; Colla corii asini is produced in Dong'e, Shandong; Ziziphus jujuba is produced in Cangzhou, Hebei; Glycyrrhiza uralensis is produced in Hang produced in Hangjinqi, Inner Mongolia; Arillus longan is produced in Bobai, Guangxi; This treatment utilizes eight medicinal herbs to enhance the body's repair capabilities and alleviate bone malnutrition caused by qi and blood deficiency, achieving the effects of replenishing qi and blood and supporting the body's vital energy. Among them, Astragalus membranaceus increases HIF1α expression levels, significantly improving the body's repair capabilities and enhancing bone qi and blood supply; Codonopsis pilosula contains codonopsis saponins, which can promote local circulation and assist in replenishing qi and blood; Rehmannia glutinosa contains Rehmannia glutinosa polysaccharides, which can effectively replenish qi and blood and provide energy for bone repair; Paeonia lactiflora contains paeoniflorin, which has anti-inflammatory effects and is safe for external use; Donkey-hide gelatin (melted), containing donkey-hide gelatin peptides, needs to be melted before being ground with other herbs to promote tissue repair; Jujube contains jujube polysaccharides, which can assist in replenishing qi and blood and enhance the body's resistance; Glycyrrhiza uralensis (processed), containing glycyrrhizic acid, can reduce inflammation and skin irritation, while also harmonizing the properties of various herbs; and Longan pulp contains longan polysaccharides, which can replenish qi and blood and provide support for the body's repair. In the wind-dispelling and dampness-removing composition, Angelica pubescens is produced in Badong, Hubei; Notopterygium incisum is produced in Aba, Sichuan; Saposhnikovia divaricata is produced in Chifeng, Inner Mongolia; Gentiana macrophylla is produced in Luoping, Yunnan; Chaenomeles speciosa is produced in Xuancheng, Anhui; Siegesbeckia orientalis is produced in Qichun, Hubei; Geranium wilfordii is produced in Suzhou, Jiangsu; Cinnamomum cassia is produced in Cinnamomum cassia, Guangxi; and Artemisia argyi is produced in Qichun, Hubei. This treatment utilizes nine medicinal herbs to warm and unblock the meridians, reducing pain sensitivity caused by cold and dampness obstructing the meridians, thus achieving the effects of dispelling wind and dampness, and warming the meridians to dispel cold. Among them, Angelica pubescens contains Angelica pubescens alcohol extract, which has anti-inflammatory effects and is safe for external use; it can warm and unblock the meridians and alleviate joint pain caused by cold and dampness. Notopterygium incisum contains Notopterygium incisum alcohol, which has a clear anti-inflammatory effect and is non-irritating to the skin when used externally; it can assist in warming the meridians to dispel cold. Saposhnikovia divaricata contains Cimicifuga foetida glycoside, which has anti-inflammatory effects and is safe for external use, relieving joint discomfort caused by wind, cold, and dampness. Gentiana macrophylla contains Gentiana macrophylla... Primuline A has significant anti-inflammatory effects and is non-toxic when applied topically; Papaya contains papain, which can loosen tissue adhesions and simultaneously help warm and unblock meridians; Siegesbeckia orientalis contains siegenin, which also has anti-inflammatory effects and is non-irritating to the skin when applied topically; Geranium wilfordii contains geranyl oleanol, which has a clear anti-inflammatory effect and is safe for topical application; Cinnamomum cassia contains cinnamaldehyde, which can warm and unblock meridians, promote drug penetration, and enhance overall efficacy; Artemisia argyi (vinegar-processed), the vinegar-processed Artemisia argyi has a stronger effect in warming and unblocking meridians and is non-irritating to the skin when applied topically.
[0013] A method for preparing a multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation is as follows: Step 1: Clean the raw materials to remove impurities and non-medicinal parts; The cleaned raw materials are placed in an oven and dried at a low temperature, with the moisture content controlled to be ≤8%; low-temperature drying avoids high temperature damage to the effective components in the medicinal materials; The dried medicinal materials are pulverized to 80-100 mesh using an ultra-micro pulverizer. The sieving process removes the incompletely pulverized residue, ensuring that the fine powder of the medicinal materials has a uniform particle size, which is conducive to the subsequent release of effective ingredients. Then weigh the medicinal materials according to the proportions, mix them, and obtain the mixture; Step 2, blending of magnetic permeability materials: Take ferric oxide@gold nanorod (Fe3O4-NRs) composite particles, add them to the mixture, and stir until uniform to obtain the blend. Stirring and mixing process ensures that the iron oxide@gold nanorods are uniformly dispersed in the mixture, guaranteeing the magnetoelectric penetration effect; Step 3, Matrix preparation: prepared using Shandong sesame oil and lead oxide as raw materials; Step 4, Mixing and spreading: Add the blend to the matrix, heat and stir evenly at 60-70℃ to obtain the ointment; This temperature range ensures that the medicinal materials and the matrix are fully integrated, while also preventing high temperatures from damaging the active ingredients in the medicinal materials. Take the ointment and spread it evenly on a 10cm×12cm non-woven fabric backing. The thickness of the spread should be controlled to be 0.5-1mm. Then cover it with a silicone paper release layer to obtain the main body of the patch. Step 5, Sterilization and Packaging: Place the prepared patch body in an irradiation sterilization device and irradiate the patch body with a dose of 8-10 kGy. After sterilization, seal the patch body in an aluminum-plastic bag to obtain the product.
[0014] Preferably, in step one, the drying temperature of the raw material is 55-60℃; the rotation speed of the ultrafine pulverizer is 3000 rpm.
[0015] Preferably, in step two, the stirring speed is 500 rpm and the stirring time is 10-15 min; the mass ratio of the mixture to the iron(III) oxide@gold nanorods is 19:1; this ratio can ensure the balance between the magnetoelectric permeation effect and the release efficiency of the active ingredients of the medicinal material; the particle size of the iron(III) oxide@gold nanorods is ≤20 nm.
[0016] Preferably, in step three, the matrix preparation process is as follows: S1, Refining: Take sesame oil from Shandong and heat it in a refining pot to 240-260℃. The sesame oil reaches the state where it can form round oil droplets when dropped into cold water without dispersing. Stir continuously during the heating process to remove impurities from the oil and obtain clear oil. S2, Adding lead oxide: Add lead oxide slowly to the clear oil at a ratio of 5:1 by mass, while stirring at high speed until the mixture is as black as lacquer and as shiny as a mirror, to obtain the ointment oil. S3, Remove Fire Toxins: Pour the prepared ointment into cold water and soak for 3 days, changing the cold water once a day to obtain the base; remove the irritating free fatty acids in the ointment (base) by water soaking, reducing the risk of skin irritation from the patch.
[0017] Preferably, in step S2, the stirring speed is ≥1000 rpm.
[0018] The bone rehabilitation physiotherapy patch provided by this invention is suitable for the prevention and rehabilitation of bone diseases and bone injury-related chronic diseases such as neck, shoulder and lumbar pain, arthritis, osteonecrosis, and post-fracture rehabilitation. The transdermal depth is ≥6cm, the onset time is ≤15min, and the duration of action is ≥72h.
[0019] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The bone rehabilitation physiotherapy patch provided by this invention is scientifically classified and proportioned according to five major functional categories: promoting blood circulation and removing blood stasis, reconnecting tendons and bones, relaxing muscles and tendons, replenishing qi and blood, and dispelling wind and dampness. The five types of medicinal materials are set in different proportions so that the resulting patch can take into account four therapeutic effects: unblocking, replenishing, warming, and eliminating. It accurately balances the pathogenesis characteristics of bone diseases, which are characterized by deficiency of the root and excess of the symptoms, and avoids the problem of incomplete treatment caused by neglecting a single effect. At the same time, it solves the defect of unbalanced compatibility of traditional patches. 2. Application of Magnetoelectric Permeation Technology: The bone rehabilitation physiotherapy patch provided by this invention is the first to add iron oxide@gold nanorod composite magnetic permeable material (particle size ≤20nm). Under the action of an external low-frequency magnetic field (magnetic field strength ≤12mT, only 1 / 10 of the safety threshold), a local stable electromagnetic field can be formed in the area where the patch contacts the skin, which significantly improves the efficiency of drug transdermal permeation, allowing the drug to penetrate to the periosteum layer. The transdermal depth can reach ≥6cm, solving the technical problem of insufficient transdermal depth of traditional patches and breaking the limitation of passive drug diffusion. 3. Multi-target drug action matrix: The bone rehabilitation physiotherapy patch provided by this invention is based on the pathological mechanism of bone diseases. It targets four key pathological links: the inflammatory pathway (inhibiting TNF-α / PGE2 expression), the analgesic pathway (blocking Nav1.8 sodium channels and activating endorphin release), the osteogenic pathway (inducing BMP7 / VEGF expression), and the angiogenesis pathway (activating HIF-1α). It designs a combination of specific active ingredients to achieve a cascade therapeutic effect of anti-inflammatory first and analgesia later, repairing and promoting bone growth simultaneously, comprehensively improving the state of bone diseases and making up for the shortcomings of traditional patches with single efficacy. 4. Balancing Safety and Low Cost: The bone rehabilitation physiotherapy patch provided by this invention eliminates highly toxic medicinal materials such as Aconitum carmichaelii and Aconitum kusnezoffii in its formulation design. For irritating medicinal materials such as frankincense and myrrh, processing techniques such as frosting, vinegar processing, and stir-frying are used to reduce irritation, ensuring safety for external use and meeting the external dosage standards of the 2020 edition of the Chinese Pharmacopoeia. All medicinal materials are from GAP-certified bases and have been tested by HPLC and ICP-MS. Pesticide residues (HCH, DDT) and heavy metals (lead ≤2ppm, arsenic ≤1ppm, cadmium ≤0.3ppm, mercury ≤0.2ppm) all meet the "Green Industry Standard for Import and Export of Medicinal Plants and Preparations." Furthermore, the materials have undergone irradiation sterilization (dose 8-10kGy), with a total bacterial count ≤1000CFU / g, mold and yeast ≤100CFU / g, and no Escherichia coli detected. 5. The preparation process of the bone rehabilitation physiotherapy patch provided by the present invention is improved based on the traditional black plaster preparation technology, adding a step of blending magnetic conduction materials. It does not require the purchase of complex microfluidic equipment, reduces production costs, and is suitable for large-scale industrial production. 6. Strong universality: The bone rehabilitation physiotherapy patch provided by the present invention is applicable to various bone diseases such as neck, shoulder, lumbar pain, arthritis, osteonecrosis, and late-stage fracture rehabilitation, covering the pathological needs of the early, middle, and late stages, and meeting the treatment needs of patients at different stages. Specific embodiments
[0020] In order to enable those skilled in the art to better understand the technical solutions in the present invention, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.
[0021] For the traditional Chinese medicine raw materials of the present invention, in the promoting blood circulation and removing blood stasis composition, Angelica sinensis is produced in Min County, Gansu; Ligusticum chuanxiong is produced in Dujiangyan, Sichuan; Carthamus tinctorius is produced in Ruoqiang, Xinjiang; Prunus persica is produced in Xiuyan, Liaoning; Salvia miltiorrhiza is produced in Ju County, Shandong; Paeonia lactiflora is produced in Duolun, Inner Mongolia; Panax notoginseng is produced in Wenshan, Yunnan; Olibanum is produced in Luliang, Yunnan; Myrrha is produced in Tunchang, Hainan; Corydalis yanhusuo is produced in Dongyang, Zhejiang; Sappanwood is produced in Baise, Guangxi; Eupatorium japonicum is produced in Yancheng, Jiangsu; Artemisia anomala is produced in Jurong, Jiangsu; Dragon's blood is produced in Danzhou, Hainan; Curcuma longa is produced in Zhangzhou, Fujian; Curcuma aromatica is produced in Shuangliu, Sichuan; Trogopterus dungarensis is produced in Yushe, Shanxi. In the composition for promoting bone fracture healing and tendon connection, Drynaria fortunei is produced in Jiande, Zhejiang; Dipsacus asperoides is produced in Leshan, Sichuan; Pyritum is produced in Xinhuang, Hunan; Eupolyphaga sinensis is produced in Xuzhou, Jiangsu; Eucommia ulmoides is produced in Zunyi, Guizhou; Cibotium barometz is produced in Wuyi Mountain, Fujian; Epimedium brevicornu is produced in Longnan, Gansu; Morinda officinalis is produced in Deqing, Guangdong; Cuscuta chinensis is produced in Anguo, Hebei; Taxillus chinensis is produced in Nanning, Guangxi; Achyranthes bidentata is produced in Wuzhi, Henan; Testudinis carapax is produced in Huzhou, Zhejiang; Concha ostreae is produced in Zhanjiang, Guangdong. In the composition for relaxing muscles and activating collaterals, Lycopodium clavatum is produced in Pan'an, Zhejiang; Speranskia tuberculata is produced in Haicheng, Liaoning; Clematis chinensis is produced in Xiangyang, Hubei; Spatholobus suberectus is produced in Nanning, Guangxi; Trachelospermum jasminoides is produced in Suzhou, Jiangsu; Piper kadsura is produced in Putian, Fujian; Sinomenium acutum is produced in Jinzhai, Anhui; Lonicera japonica is produced in Fengqiu, Henan; Ramulus mori is produced in Suzhou, Jiangsu; Fructus luffae is produced in Cixi, Zhejiang. In the composition for tonifying qi and blood, Astragalus membranaceus is produced in Longxi, Gansu; Codonopsis pilosula is produced in潞党, Shanxi; Rehmannia glutinosa is produced in Wuzhi, Henan; Paeonia lactiflora is produced in Dongyang, Zhejiang; Colla corii asini is produced in Dong'e, Shandong; Ziziphus jujuba is produced in Cangzhou, Hebei; Glycyrrhiza uralensis is produced in Hangjin Banner, Inner Mongolia; Arillus longan is produced in Bobai, Guangxi. In the wind-dispelling and dampness-removing composition, Angelica pubescens is produced in Badong, Hubei; Notopterygium incisum is produced in Aba, Sichuan; Saposhnikovia divaricata is produced in Chifeng, Inner Mongolia; Gentiana macrophylla is produced in Luoping, Yunnan; Chaenomeles speciosa is produced in Xuancheng, Anhui; Siegesbeckia orientalis is produced in Qichun, Hubei; Geranium wilfordii is produced in Suzhou, Jiangsu; Cinnamomum cassia is produced in Rougui, Guangxi; and Artemisia argyi is produced in Qichun, Hubei.
[0022] Example 1 A multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation, each patch contains 19g of traditional Chinese medicine composition, and each patch contains the following components by weight: The composition includes: 5.2g of blood-activating and stasis-removing composition, 4.5g of tendon-repairing and bone-setting composition, 3.6g of muscle-relaxing and collateral-activating composition, 3.1g of qi- and blood-tonifying composition, and 2.6g of wind-dispelling and dampness-removing composition. The blood-activating and stasis-removing composition comprises the following raw materials by weight: Angelica sinensis 0.54g, Ligusticum chuanxiong 0.43g, Carthamus tinctorius 0.28g, Prunus persica 0.28g, Salvia miltiorrhiza 0.41g, Paeonia lactiflora 0.28g, Panax notoginseng 0.16g, Boswellia carterii (processed) 0.27g, Commiphora myrrha (processed) 0.31g, Corydalis yanhusuo 0.43g, Sappanwood 0.27g, Lycopus lucidus 0.28g, Artemisia capillaris 0.28g, Daemonorops draco 0.14g, Curcuma longa 0.29g, Curcuma aromatica 0.26g, Trogopterus xanthipes (vinegar-processed) 0.29g; The tendon-healing and bone-setting composition comprises the following raw materials by weight: Drynaria fortunei 0.55g, Dipsacus asper 0.41g, natural copper (calcined) 0.41g, ground beetle (fried) 0.28g, Eucommia ulmoides 0.41g, Cibotium barometz (scalded) 0.27g, Epimedium brevicornu 0.28g, Morinda officinalis 0.28g, Cuscuta chinensis (salt-processed) 0.27g, Taxillus chinensis 0.40g, Achyranthes bidentata 0.41g, tortoise shell (vinegar-processed) 0.27g, oyster shell (calcined) 0.26g; The muscle-relaxing and blood-activating composition comprises the following ingredients by weight: 0.47g of *Shenjincao*, 0.46g of *Tougucao*, 0.31g of *Weilingxian*, 0.46g of *Jixueteng*, 0.32g of *Luoshiteng*, 0.32g of *Haifengteng*, 0.32g of *Qingfengteng*, 0.31g of *Rindongteng*, 0.31g of *Sangzhi*, and 0.32g of *Sigualu*. The Qi-nourishing and blood-tonifying composition comprises the following ingredients by weight: Astragalus membranaceus 0.62g, Codonopsis pilosula 0.45g, Rehmannia glutinosa 0.46g, Paeonia lactiflora 0.32g, Colla corii asini (melted) 0.31g, Ziziphus jujuba 0.31g, Glycyrrhiza uralensis (processed) 0.32g, Longan aril 0.31g; The wind-dispelling and dampness-removing composition comprises the following ingredients by weight: Angelica pubescens 0.29g, Notopterygium incisum 0.28g, Saposhnikovia divaricata 0.29g, Gentiana macrophylla 0.29g, Chaenomeles speciosa 0.30g, Siegesbeckia orientalis 0.29g, Geranium wilfordii 0.28g, Cinnamomum cassia twig 0.30g, Artemisia argyi (vinegar-processed) 0.28g; This blood-activating and stasis-removing composition utilizes 17 medicinal herbs to open local microcirculation channels, reduce inflammatory factor levels, and relieve swelling and pain caused by blood stasis. Among them, Angelica sinensis can open TRPV1 channels, promote local microcirculation, and reduce the levels of inflammatory factors such as IL6 and TNFα; Ligusticum chuanxiong contains ligustrazine, which can promote local blood circulation; Carthamus tinctorius has high safety for external use and can help improve blood stasis; Prunus persica, after being stir-fried, can synergistically enhance the blood-activating effect without any safety risks; Salvia miltiorrhiza contains tanshinone components, which also have anti-inflammatory effects and cause no significant skin irritation when applied externally; Paeonia lactiflora contains paeoniflorin, which can exert anti-inflammatory and analgesic effects; Panax notoginseng contains notoginsenoside Rg1, which can promote tissue repair, and the micronized powder causes no skin irritation when applied externally; and Boswellia carterii (processed), after being processed... After degreasing, the irritation is reduced, and it contains boswellic acid, which can reduce inflammation and swelling; Myrrh (processed), also processed to remove oil, contains bisabolol, which has a significant analgesic effect; Corydalis contains corydaline, which has high bioavailability for external use and can effectively relieve pain; Sappanwood contains brassicatin, which can assist in anti-inflammation; Lycopus lucidus contains lycopodium, which can improve local blood circulation; Artemisia capillaris contains artemisia flavonoids, which can enhance the effects of promoting blood circulation and anti-inflammation when used externally in traditional methods; Dragon's blood contains daemonone, which has both anti-inflammatory and tissue-regenerating effects; Curcuma longa contains curcumin, which has a clear anti-inflammatory effect and high bioavailability for external use; Curcuma aromatica contains curcuminoids, which have no risk of hepatotoxicity when used externally and can assist in promoting blood circulation; Trogopterus xanthipes (vinegar-processed), after being processed with vinegar, has a reduced fishy smell and contains trogopterus xanthipes, which can promote local circulation; In this bone-healing composition, 13 medicinal herbs are used to promote osteoblast proliferation, accelerate callus formation and trabecular bone reconstruction, and enhance bone toughness, achieving the effects of bone healing and strengthening tendons and bones. Among them, *Drynaria fortunei* can increase BMP7 expression levels to promote osteoblast proliferation and increase VEGF secretion, thus aiding in trabecular bone reconstruction; *Dipsacus asper* contains dipsacus saponin VI, which can promote callus formation; calcined natural copper, after calcination, makes ferrous iron more easily absorbed, accelerating bone healing; stir-fried ground beetle, after stir-frying, has a reduced fishy odor and contains ground beetlein I, which can promote tissue repair; *Eucommia ulmoides* contains eucommia gum, which can promote collagen synthesis and enhance bone toughness; and *Cibotium barometz* (scalded), after... After the poaching process removes the downy hairs, there is no skin irritation. It contains hyoscyamine, which can promote local circulation to aid bone repair. Epimedium contains icariin, which has an osteogenic effect. Morinda officinalis contains Morinda officinalis polysaccharide, which can enhance immune function and support bone repair. Cuscuta chinensis (salt-processed) guides the drug to act on the lower burner through salt processing. It contains cuscuta glycoside, which can assist in anti-inflammation to reduce inflammation interference in bone damage. Loranthus parasiticus contains loranthus glycoside, which can promote cartilage repair. Achyranthes bidentata contains achyranthes saponins, which can promote local circulation and deliver nutrients to the bones. Tortoise shell (vinegar-processed) contains tortoise shell glue after removing calcium and phosphorus through vinegar processing, which can promote tissue repair. Oyster shell (calcined) contains calcium carbonate after calcination, which can supplement bone minerals and help strengthen bones. This muscle-relaxing and blood-activating composition utilizes 10 medicinal herbs to inhibit synovial inflammation, loosen tissue adhesions, and improve joint mobility, achieving the effects of relaxing muscles and tendons and promoting joint mobility. Among them, *Lycopodium clavatum* can inhibit the NFκB signaling pathway, reduce synovial inflammation, and effectively improve joint mobility; *Clematis chinensis* contains clematisin, which has a clear anti-inflammatory effect and strong external penetration ability, reaching deep into the joint area; *Clematis armandii* contains clematisin, which can loosen tissue adhesions and relieve joint stiffness; and *Spatholobus suberectus* contains spatholobus glycoside, which can promote local... Local circulation is improved, providing nutrients to the joints; Trachelospermum jasminoides contains trachelospermum jasminoides glycoside, which has anti-inflammatory effects and is non-irritating to the skin when applied topically; Piper kadsura contains piperine, which can exert analgesic effects and reduce joint pain; Sinomenium acutum contains sinomenine, which has significant anti-inflammatory effects, but the dosage needs to be controlled to ensure safety; Lonicera japonica contains chlorogenic acid, which can assist in anti-inflammatory treatment and is not contraindicated for external use; Morus alba contains mulberry twig polysaccharide, which can promote local circulation and relieve congestion around the joints; Luffa cylindrica contains Luffa cylindrica saponins, which can loosen tissue adhesions and improve joint mobility. This formula for replenishing Qi and blood utilizes eight medicinal herbs to enhance the body's repair capabilities and alleviate the malnutrition of bones caused by Qi and blood deficiency, achieving the effects of replenishing Qi and blood and supporting the body's vital energy. Among them, Astragalus membranaceus increases HIF1α expression levels, significantly enhancing the body's repair capabilities and improving the supply of Qi and blood to bones; Codonopsis pilosula contains codonopsis saponins, which can promote local circulation and assist in replenishing Qi and blood; Rehmannia glutinosa contains Rehmannia glutinosa polysaccharides, which can effectively replenish Qi and blood and provide energy for bone repair; Paeonia lactiflora contains paeoniflorin, which has anti-inflammatory effects and is safe for external use; Donkey-hide gelatin (melted), containing donkey-hide gelatin peptides, needs to be melted before being ground with other medicinal herbs to promote tissue repair; Jujube contains jujube polysaccharides, which can assist in replenishing Qi and blood and enhance the body's resistance; Glycyrrhiza uralensis (processed), containing glycyrrhizic acid, can reduce inflammation and skin irritation, while also harmonizing the properties of various medicinal herbs; and Longan pulp contains longan polysaccharides, which can replenish Qi and blood and provide support for the body's repair. In this wind-dispelling and dampness-removing composition, nine medicinal herbs are used to warm and unblock the meridians, reduce pain sensitivity caused by cold and dampness obstructing the meridians, and achieve the effects of dispelling wind and dampness, warming the meridians and dispersing cold. Among them, Angelica pubescens contains Angelica pubescens alcohol extract, which has anti-inflammatory effects and is safe for external use. It can warm and unblock the meridians and relieve joint pain caused by cold and dampness. Notopterygium incisum contains Notopterygium alcohol, which has a clear anti-inflammatory effect and does not irritate the skin when used externally. It can assist in warming the meridians and dispersing cold. Saposhnikovia divaricata contains Cimicifuga glycoside, which has anti-inflammatory effects and is safe for external use. It can relieve joint discomfort caused by wind, cold and dampness. Gentian root, containing gentianine A, has significant anti-inflammatory effects and is non-toxic when applied topically; papaya, containing papain, can loosen tissue adhesions and simultaneously aid in warming and unblocking meridians; Siegesbeckia orientalis, containing siegesin, also has anti-inflammatory effects and is non-irritating to the skin when applied topically; Geranium wilfordii, containing geranyl oleracea, has a clear anti-inflammatory effect and is safe for topical application; Cinnamomum cassia, containing cinnamaldehyde, can warm and unblock meridians, promote drug penetration, and enhance overall efficacy; Artemisia argyi (vinegar-processed), the vinegar-processed Artemisia argyi has a stronger effect in warming and unblocking meridians and is non-irritating to the skin when applied topically. The preparation method of the above-mentioned multi-target bone rehabilitation physiotherapy patch based on yin-yang balance and magnetoelectric permeation is as follows: Step 1: Clean the raw materials to remove impurities and non-medicinal parts; The cleaned medicinal materials are placed in an oven and dried at a low temperature of 60℃ to control the moisture content to 4.5%; low-temperature drying avoids high temperature damage to the effective components in the medicinal materials; The dried raw materials are pulverized to 80-100 mesh using an ultra-micro pulverizer at a speed of 3000 rpm. The pulverizer is then sieved to remove any incompletely pulverized residue. This sieving process ensures that the fine powder of the medicinal materials has a uniform particle size, which is beneficial for the subsequent release of active ingredients. Then weigh the medicinal materials according to the proportions, mix them, and obtain the mixture; Step 2, blending of magnetic permeability materials: Take ferric oxide@gold nanorod (Fe3O4-NRs) composite particles, add them to the mixture, and the mass ratio of the mixture to the ferric oxide@gold nanorod is: 19:1 ; The mixture was stirred at 500 rpm for 10 minutes until homogeneous, resulting in a blend. Stirring and mixing process ensures that the ferric oxide@gold nanorods (commercially available) are evenly dispersed in the mixture, guaranteeing the magnetoelectric penetration-enhancing effect; The particle size of the iron(III) oxide@gold nanorods is 8-11 nm; This ratio ensures a balance between the magnetic permeation-enhancing effect and the release efficiency of the active ingredients in the medicinal materials; Step 3, Matrix Preparation: S1, Refining: Take sesame oil from Shandong and heat it to 260°C in a refining pot until the sesame oil reaches the state of forming beads when dropped into cold water. Stir continuously during the heating process to remove impurities from the oil and obtain clear oil. S2, Adding lead oxide: Add lead oxide slowly to the clear oil at a ratio of 5:1 by mass, while stirring at high speed at 1500 rpm until the mixture is as black as lacquer and as shiny as a mirror, thus obtaining the ointment oil. S3, Detoxification: Pour the prepared ointment into cold water and soak for 3 days, changing the cold water once a day to obtain the base; remove the irritating free fatty acids in the ointment (base) by water soaking, reducing the risk of skin irritation from the patch; Step 4, Mixing and spreading: Add the blend to the matrix and heat and stir evenly at 65°C to obtain the ointment; this temperature range can ensure that the medicinal materials and the matrix are fully integrated, and can avoid the destruction of the effective ingredients in the medicinal materials by high temperature; Take the ointment and spread it evenly on a 10cm×12cm non-woven fabric backing. The thickness of the spread should be controlled to be 0.5-1mm. Then cover it with a silicone paper release layer to obtain the main body of the patch. Step 5, Sterilization and Packaging: Place the prepared patch body in an irradiation sterilization device and irradiate the patch body with a dose of 8kGy. After sterilization, seal the patch body in an aluminum-plastic bag to obtain the product.
[0023] test In the following tests, the product prepared in Example 1 was used as the experimental sample for testing; 1. Verification of enhanced transdermal depth: Transdermal experiments were conducted using the in vitro Franz diffusion cell method. The results showed that under the action of an external low-frequency magnetic field ≤12mT (1 / 10 of the human body's safe magnetic field threshold (≤120mT)), the active ingredients such as sinomenine and total flavonoids of Drynaria fortunei in the product (patch) prepared in Example 1 could still be detected at significant concentrations in skin tissue at a depth of 6cm (confirmed by HPLC detection). Among them, the cumulative release of sinomenine at a depth of 6cm was 42%, while that of traditional plasters was only 12%. This proves that the magnetoelectric permeation technology of the present invention can effectively improve the transdermal depth of drugs, allowing the drugs to directly reach the bone and joint lesions.
[0024] 2. Verification of multi-target synergistic effects Animal experiments: A rat osteonecrosis model (induced by hormones) and a rat calcaneal fracture model were established respectively. The patch of this invention was applied to the model rats, and relevant indicators were detected. The results showed that the product (patch) prepared in Example 1 could significantly reduce the level of IL-6 (inflammatory factor) in rat serum (P<0.01). Among them, the serum IL-6 level in the osteonecrosis model rats decreased by 58%; at the same time, it increased the expression level of VEGF (vascular endothelial growth factor, which promotes angiogenesis and bone repair) and activated the release of endorphins (analgesic substances); the patch had an onset time of 10 minutes and a duration of action of 80 hours; Furthermore, it can significantly increase the callus density in fracture model rats (P<0.05), and the callus density in osteonecrosis model rats is 35% higher than that in the model group (P<0.01), proving that the patch of the present invention has a multi-target synergistic therapeutic effect; Clinical observation: 100 patients with knee osteoarthritis and 100 patients with neck, shoulder, back and leg pain were selected and treated with the patch of this invention for 2 weeks. The results showed that the VAS (Visual Analogue Scale) score of patients with knee osteoarthritis decreased from 7.2±1.1 before treatment to 3.1±0.8 after treatment, with a pain relief rate of 57% and an overall effective rate of 94%. Among patients with neck, shoulder, back and leg pain, 90% of patients experienced a reduction of ≥50% in VAS scores after treatment, with a total effective rate of 92%, demonstrating that the patch of this invention has significant efficacy in clinical applications.
[0025] 3. Security Verification Acute toxicity test: The product (patch) prepared in Example 1 was applied to the skin on the back of healthy rats for 7 consecutive days, and the skin reaction of the rats was observed. The results showed that no irritation reactions such as redness, swelling, itching, or ulceration occurred on the skin of the rats, proving that the patch is highly safe for external use. Microbial testing: The product (patch) prepared in Example 1 was tested for microbial indicators; The results showed that the total bacterial count was ≤1000 CFU / g, the mold and yeast count was ≤100 CFU / g, and Escherichia coli was not detected, which met the standards for medicinal microorganisms. Safety of medicinal materials: All selected medicinal materials are listed in the Chinese Pharmacopoeia (2020 edition). The external dosage is lower than the oral dosage specified in the Chinese Pharmacopoeia (e.g., frankincense and myrrh are 3-10g / day orally, and half the amount for external use; Panax notoginseng is 3-9g / day orally, and 0.5g / patch for external use is safe). In addition, the materials have been processed to reduce toxicity and irritation, further ensuring safe use.
[0026] The above experiments show that the safety threshold control process for low-frequency magnetic field strength (≤12mT) in this invention can ensure the permeation promotion effect while avoiding the safety risks of magnetic field to the human body. The medicinal materials used in this invention are all from GAP-certified bases. HPLC and ICP-MS tests show that pesticide residues (HCH, DDT) and heavy metals (lead ≤ 2 ppm, arsenic ≤ 1 ppm, cadmium ≤ 0.3 ppm, mercury ≤ 0.2 ppm) comply with the "Green Industry Standard for Import and Export of Medicinal Plants and Preparations".
[0027] The product is sterilized by irradiation (dose 8-10kGy), with a total bacterial count ≤1000CFU / g, molds and yeasts ≤100CFU / g, and Escherichia coli not detected.
[0028] This invention integrates the scientific principles of traditional Chinese medicine's Yin-Yang balance with the precision of modern magnetoelectric permeation technology. Through carefully selected medicinal materials and optimized formulation design (scientifically proportioned according to five functional categories: promoting blood circulation and removing blood stasis, promoting tendon and bone healing, relaxing muscles and tendons, replenishing Qi and blood, and dispelling wind and dampness), it achieves a comprehensive response to the underlying pathogenesis of bone diseases. At the same time, it improves upon the traditional black plaster preparation process by adding only a magnetic material blending step, significantly reducing production costs and making it suitable for large-scale industrial production. Experimental verification shows that this invention's patch possesses core advantages such as deep transdermal penetration, multiple targets, high safety, and wide applicability. Its transdermal depth can reach over 6cm, with 42% of sinomenine cumulatively released at a depth of 6cm, enabling the drug to directly reach bone and joint lesions. It can simultaneously act on four major pathological pathways: inflammation, analgesia, osteogenic regeneration, and angiogenesis. Animal experiments showed a 35% increase in callus density and a 58% reduction in IL-6, with a total clinical efficacy exceeding 92%, achieving synergistic treatment. It has high external safety, with no significant skin irritation, and the pesticide residues, heavy metals, and microbial indicators of the medicinal materials all meet standards. It is suitable for various bone diseases such as neck, shoulder, and lumbar pain, arthritis, osteonecrosis, and post-fracture rehabilitation, covering the needs of the entire disease course. In summary, this invention has significant clinical application value and strong patent protection, and can be widely applied in the field of bone disease treatment, providing patients with efficient and safe treatment options. At the same time, it provides new technical ideas for the modernization of traditional Chinese medicine external preparations, and has both social and economic benefits.
[0029] Although the present invention has been described in detail with reference to preferred embodiments, it is not limited thereto. Various equivalent modifications or substitutions can be made to the embodiments of the present invention by those skilled in the art without departing from the spirit and essence of the invention, and such modifications or substitutions should all be within the scope of the present invention. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should also be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be determined by the scope of the claims.
Claims
1. A multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation, characterized in that, Each patch contains 19g of the herbal composition, which comprises the following components by weight: The composition includes 5.2g of blood-activating and stasis-removing composition, 4.5g of tendon-repairing and bone-setting composition, 3.6g of muscle-relaxing and collateral-activating composition, 3.1g of qi- and blood-tonifying composition, and 2.6g of wind-dispelling and dampness-removing composition.
2. The multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation as described in claim 1, characterized in that, The blood-activating and stasis-removing composition comprises the following raw materials by weight: Angelica sinensis 0.53-0.56g, Ligusticum chuanxiong 0.40-0.43g, Carthamus tinctorius 0.27-0.29g, Prunus persica 0.27-0.30g, Salvia miltiorrhiza 0.40-0.43g, Paeonia lactiflora 0.27-0.31g, Panax notoginseng 0.12-0.17g, Boswellia carterii (processed) 0.27-0.29g, Commiphora myrrha (processed) 0.28-0.32g, Corydalis yanhusuo 0.41-0.44g, Sappanwood 0.25-0.28g, Lycopus lucidus 0.27-0.30g, Artemisia capillaris 0.27-0.29g, Daemonorops draco 0.12-0.15g, Curcuma longa 0.25-0.30g, Curcuma aromatica 0.27-0.30g, Trogopterus xanthipes (vinegar-processed) 0.26-0.33g.
3. The multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation as described in claim 1, characterized in that, The tendon-repairing and bone-setting composition comprises the following raw materials by weight: Drynaria fortunei 0.53-0.55g, Dipsacus asper 0.39-0.42g, Calcined natural copper 0.40-0.43g, Fried ground beetle 0.25-0.30g, Eucommia ulmoides 0.39-0.42g, Cibotium barometz 0.25-0.28g, Epimedium 0.26-0.29g, Morinda officinalis 0.26-0.29g, Cuscuta chinensis (salt-processed) 0.25-0.30g, Taxillus chinensis 0.39-0.41g, Achyranthes bidentata 0.40-0.42g, Tortoise shell (vinegar-processed) 0.25-0.28g, Oyster shell (calcined) 0.25-0.31g.
4. The multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation as described in claim 1, characterized in that, The muscle-relieving and blood-activating composition comprises the following ingredients by weight: 0.45-0.49g of *Shenjincao*, 0.45-0.50g of *Tougucao*, 0.30-0.33g of *Weilingxian*, 0.45-0.49g of *Jixueteng*, 0.30-0.35g of *Luoshiteng*, 0.31-0.35g of *Haifengteng*, 0.30-0.33g of *Qingfengteng*, 0.30-0.33g of *Rindongteng*, 0.29-0.35g of *Sangzhi*, and 0.30-0.34g of *Sigualu*.
5. The multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation as described in claim 1, characterized in that, The qi-tonifying and blood-nourishing composition comprises the following ingredients by weight: Astragalus membranaceus 0.60-0.65g, Codonopsis pilosula 0.43-0.47g, Rehmannia glutinosa 0.45-0.48g, Paeonia lactiflora 0.30-0.34g, Colla corii asini (melted) 0.30-0.33g, Ziziphus jujuba 0.30-0.32g, Glycyrrhiza uralensis (processed) 0.30-0.33g, Longan aril 0.30-0.34g.
6. The multi-target bone rehabilitation physiotherapy patch based on Yin-Yang balance and magnetoelectric permeation as described in claim 1, characterized in that, The wind-dispelling and dampness-removing composition comprises the following raw materials by weight: Angelica pubescens 0.28-0.31g, Notopterygium incisum 0.27-0.30g, Saposhnikovia divaricata 0.28-0.31g, Gentiana macrophylla 0.27-0.30g, Chaenomeles speciosa 0.29-0.33g, Siegesbeckia orientalis 0.27-0.30g, Geranium wilfordii 0.27-0.30g, Cinnamomum cassia twig 0.28-0.35g, Artemisia argyi (vinegar-processed) 0.27-0.29g.
7. A method for preparing a multi-target bone rehabilitation physiotherapy patch based on yin-yang balance and magnetoelectric permeation as described in claim 1, characterized in that, The process is as follows: Step 1: Clean the raw materials to remove impurities and non-medicinal parts; The cleaned medicinal materials are placed in an oven and dried at a low temperature, controlling the moisture content to ≤8%; low temperature drying; Use an ultra-fine pulverizer to pulverize the dried raw materials to 80-100 mesh, and then sieve to remove any incompletely pulverized residue. Then weigh the medicinal materials according to the proportions, mix them, and obtain the mixture; Step 2, blending of magnetic permeability materials: Take ferric oxide@gold nanorod composite particles, add them to the mixture, and stir until uniform to obtain the blend; Step 3, Matrix preparation: prepared using Shandong sesame oil and lead oxide as raw materials; Step 4, Mixing and spreading: Add the blend to the matrix, heat and stir evenly at 60-70℃ to obtain the ointment; Take the ointment and spread it evenly on a 10cm×12cm non-woven fabric backing. The thickness of the spread should be controlled to be 0.5-1mm. Then cover it with a silicone paper release layer to obtain the patch body. Step 5, Sterilization and Packaging: Place the prepared patch body in an irradiation sterilization device and irradiate the patch body with a dose of 8-10 kGy. After sterilization, seal the patch body in an aluminum-plastic bag to obtain the product.
8. The preparation method of the multi-target bone rehabilitation physiotherapy patch based on yin-yang balance and magnetoelectric permeation as described in claim 7, characterized in that, In step one, the drying temperature of the raw material is 55-60℃; the rotation speed of the ultrafine pulverizer is 3000 rpm.
9. The preparation method of the multi-target bone rehabilitation physiotherapy patch based on yin-yang balance and magnetoelectric permeation as described in claim 7, characterized in that, In step two, the stirring speed is 500 rpm and the stirring time is 10-15 min; the mass ratio of the mixture to the iron(III) oxide@gold nanorods is 19:
1.
10. The preparation method of the multi-target bone rehabilitation physiotherapy patch based on yin-yang balance and magnetoelectric permeation as described in claim 7, characterized in that, In step three, the matrix preparation process is as follows: S1, Refining: Take sesame oil from Shandong, place it in a refining pot and heat it to 240-260℃. Stir constantly during the heating process to remove impurities from the oil and obtain clear oil. S2, Adding lead oxide: Add lead oxide slowly to the clear oil at a ratio of 5:1 by mass, while stirring at high speed until the mixture is as black as lacquer and as shiny as a mirror, to obtain the ointment oil. S3, Remove Fire Toxin: Pour the prepared ointment into cold water and soak for 3 days, changing the cold water once a day to obtain the base.